Ben Venue Manufacturing Pause Extended to Q4 2012

Troubled sterile injectable maker Ben Venue Laboratories is extending its voluntary manufacturing pause as major reconstruction in one wing of its now shuttered Bedford, Ohio, plant will take nine months to complete.

Ben Venue is continuing a site-wide assessment and will resume production as it addresses manufacturing issues — likely one line at a time. While some manufacturing will begin in the first quarter of 2012, work on the North facility may delay shipment of finished products from that plant until the fourth quarter.

The Boehringer Ingelheim subsidiary temporarily closed the plant last year to correct lingering good manufacturing practice issues. When plant personnel failed to investigate more than 1,200 microbial contaminants over a 14-month period, it sparked a regulatory firestorm. The fallout? Legal expenses, lost sales, plant reconstruction and delayed shipments.

And Ben Venue is not alone. Other drugmakers cited for environmental monitoring failures in recent years include Cephazone Pharma, Sanofi-Aventis and CP Pharmaceuticals.

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Requirements for Effective Environmental Monitoring Plans: Six “Must-Have” Factors to Assure Contamination Control will show you how to review your current operations to make sure you’ve mastered all six factors for complete contamination control. If you’re a biologic, sterile drug, or contract manufacturer, this is one webinar you simply can’t afford to miss. Reserve your space now.